FDA.reportPublic FDA data

Abstral

Product NDC
42747-228
11-digit product format
427470228
Labeler code
42747
Product ID
42747-228_d07bb89b-1d6e-43a0-839d-d85a8f0619c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
ProStrakan, Inc.
Application
NDA022510
Marketing category
NDA
Marketing start
2011-01-07
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
800 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42747-228-322019-11-27C16284748780-19855d018-ddf6-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42747-228-32Abstral32 in 1 BLISTER PACKTABLET323

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42747-228-32EA - Each42747-2281f548796-3f3d-4936-949d-481a271c278112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3
FENTANYLACTIVE MOIETYUF599785JZABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42747-228ABSTRAL (FENTANYL) TABLET [PROSTRAKAN, INC.]3Legacy NDC, 1 package rows20121120_4906457e-30ad-4da7-b3ac-bb9e6651a670.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053651ABSTRAL 100 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053654ABSTRAL 200 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053657ABSTRAL 300 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053660ABSTRAL 400 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053663ABSTRAL 600 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053666ABSTRAL 800 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053647fentaNYL 100 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053652fentaNYL 200 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053655fentaNYL 300 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053658fentaNYL 400 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053661fentaNYL 600 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053664fentaNYL 800 MCG Sublingual TabletPSN4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053651fentanyl 0.1 MG Sublingual Tablet [Abstral]SBD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053654fentanyl 0.2 MG Sublingual Tablet [Abstral]SBD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053657fentanyl 0.3 MG Sublingual Tablet [Abstral]SBD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053660fentanyl 0.4 MG Sublingual Tablet [Abstral]SBD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053663fentanyl 0.6 MG Sublingual Tablet [Abstral]SBD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053666fentanyl 0.8 MG Sublingual Tablet [Abstral]SBD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053647fentanyl 0.1 MG Sublingual TabletSCD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053652fentanyl 0.2 MG Sublingual TabletSCD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053655fentanyl 0.3 MG Sublingual TabletSCD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053658fentanyl 0.4 MG Sublingual TabletSCD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053661fentanyl 0.6 MG Sublingual TabletSCD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053664fentanyl 0.8 MG Sublingual TabletSCD4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053651Abstral (as fentanyl citrate) 100 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053654Abstral (as fentanyl citrate) 200 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053657Abstral (as fentanyl citrate) 300 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053660Abstral (as fentanyl citrate) 400 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053663Abstral (as fentanyl citrate) 600 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053666Abstral (as fentanyl citrate) 800 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053651Abstral 0.1 MG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053654Abstral 0.2 MG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053657Abstral 0.3 MG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053660Abstral 0.4 MG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053663Abstral 0.6 MG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053666Abstral 0.8 MG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053647fentanyl (as fentanyl citrate) 100 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053652fentanyl 200 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053655fentanyl 300 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053658fentanyl 400 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053661fentanyl 600 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703
1053664fentanyl 800 MCG Sublingual TabletSY4906457e-30ad-4da7-b3ac-bb9e6651a6703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42747-228-324274702283232 in 1 BLISTER PACKHistorical